Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
Abstract
Data availability statement: Data are available upon reasonable request. Data will be made available on the Figshare data repository.Objective: To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke. Design: A feasibility randomised controlled trial with a parallel process evaluation. Setting: Acute Stroke Unit and participants’ homes (London, UK). Participants: 24 adults (>18 years), acute and subacute poststroke, new unilateral weakness, scoring 9–25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate. Interventions: Participants randomised to the intervention or control group on a 2:1 ratio. The intervention group (n=16) received usual care plus the Neurofenix platform for 7 weeks. The control group (n=8) received usual care only. Outcomes: Safety was assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility was assessed through training and support requirements and intervention fidelity. Acceptability was assessed through a satisfaction questionnaire. Impairment, activity and participation outcomes were also collected at baseline and 7 weeks to assess their suitability for use in a definitive trial. Randomisation: Computer-generated, allocation sequence concealed by opaque, sealed envelopes. Blinding: Participants and assessors were not blinded; statistician blinded for data processing and analysis. Results: 192 stroke survivors were screened for eligibility, and 24 were recruited and randomised. Intervention group: n=16, mean age 66.5 years; median 9.5 days post stroke. Control group: n=8, mean age 64.6 years; median 17.5 days post stroke. Three participants withdrew before the 7-week assessment, n=21 included in the analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. The median (IQR) time to train participants was 98 (64) min over 1–3 sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 min extra per week. The mean satisfaction score was 34.9 out of 40. Conclusion: The Neurofenix platform is safe, feasible and well accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. There was a wide range of engagement with the platform in a cohort of stroke survivors which was varied in age and level of impairment. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible. Trial registration number: ISRCTN11440079.This work was supported by The Stroke Association and MedCity grant number SA MC 21\10001Similar works
Full text
Last time updated on 03/02/2025
This paper was published in Brunel University Research Archive.
Having an issue?
Is data on this page outdated, violates copyrights or anything else? Report the problem now and we will take corresponding actions after reviewing your request.